A scientific research to prove the safety and effectiveness of TVS 0 – 4 mmHg as a target of resuscitation using furosemide, to improve Perfused Vessel Density (PVD) > 25 mm / mm2, AKI stage (based on KDIGO criteria), CI > 2.5 cc / min / m2 , prevent the incidence of intubation, reduce the duration of ventilator use <120 hours and reduce the length of ICU stay in patients with septic shock after resuscitation
Full Title of Study: “Effectiveness of Fluid Deresuscitation With Central Venous Pressure Target 0-4 mmHg on Capillary Perfusion Density, Acute Kidney Injury Stage, Cardiac Index, and the Intensive Care Unit Length of Stay in Septic Shock Patients After Resuscitation”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Outcomes Assessor)
- Study Primary Completion Date: June 30, 2020
The study aims to evaluate the effectiveness of deresuscitation with target CVP 0 – 4 mmHg on septic shock patients in the ICU on capillary perfusion density, AKI stage (based on KDIGO criteria), the incidence of intubation, duration of use of mechanical ventilation, and length of stay in the ICU which can reduce the number of morbidity and mortality.
The study evaluates the difference in capillary perfusion density, AKI stage (based on KDIGO criteria), and the Cardiac index value between groups septic shock patients with CVP 0-4 mmHg on the 7th day after deresuscitation compared with the control group (CVP 8-10 mmHg on the first 7th day after being given deresuscitation).
The study evaluates the difference in the number of intubation incidents, duration of use ventilators, and care in the ICU between groups of patients with septic shock CVP 0 – 4 on day 28 after being given a degree of comparison with a control group (CVP 8-10 mmHg on day 28th after being deresuscitation).
- Procedure: Fluid resuscitation and furosemide administration (bolus and continuous) with central venous pressure target 8 – 10 mmHg
- Crystalloid loading or furosemide administration with the CVP target 8-10 mmHg is reached in septic shock patients
- Procedure: Fluid deresuscitation and furosemide administration (bolus and continuous) with central venous pressure target 0 – 4 mmHg
- active fluid removal with furosemide bolus and continuous or crystalloid loading until the CVP target 0-4 mmHg is reached in septic shock patients
Arms, Groups and Cohorts
- Active Comparator: Central Venous Pressure 8 – 10 mmHg
- Furosemide deresuscitation or crystalloid loading until the CVP target 8-12 mmHg is reached
- Experimental: Central Venous Pressure 0 – 4 mmHg
- Furosemide deresuscitation or crystalloid loading until the CVP target 0-4 mmHg is reached
Clinical Trial Outcome Measures
- Capillary Perfusion Density
- Time Frame: 7 days
- Capillary Perfusion Density measurement using MicroScan every 24 hours during deresuscitation
- Acute Kidney Injury Stage
- Time Frame: 7 days
- AKI staging using KDIGO criteria every 24 hours during deresuscitation
- Cardiac Index
- Time Frame: 7 days
- cardiac index measurement using bio-impedance cardiometry every 24 hours during deresuscitation
- Neutrophil Gelatinase-Associated lipocalin (NGAL)
- Time Frame: 1st and 7th day
- NGAL measurement from urinary sample using NGAL ELISA method at 1st and 7th day during deresuscitation
- Renal Resistive Index (RRI)
- Time Frame: 1st and 7th day
- RRI measurement using renal doppler ultrasonography at 1st and 7th day during deresuscitation
- Length of ICU stay
- Time Frame: 28 days
- length of ICU stay in days during and after deresuscitation
Participating in This Clinical Trial
- Septic shock patients who meet the diagnosis criteria for quick SOFA and KDIGO 1 stage AKI (creatinine value 1.5 times OR creatinine value> 0.3 initial OR urine production <0.5 ml/kg/hour for 6-12 hours
- Patients, both men and women, in the age range of 18 – 60 years
- Patients who experience post clean operative sepsis
- Patients who agree to attend the study by signing informed consent
- Patients with primary heart problems, right or heart failure suffer from congenital heart disease
- Have severe chronic obstructive pulmonary disease, patients with severe pleural effusion
- Patients who, based on ultrasound examination, found stones or tumors in the kidney during the study period
- CKD patients are based on history taking and physical examination
- DNR (do not resuscitate) patients
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Indonesia University
- Provider of Information About this Clinical Study
- Principal Investigator: Dita Aditianingsih, MD, PhD, Anesthesiologist Consultant – Indonesia University
- Overall Contact(s)
- Dita Aditianingsih, M.D, Ph.D, +628151819244, firstname.lastname@example.org
Citations Reporting on Results
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